J&J says batch of COVID-19 jab ingredient fails to meet quality standards
Johnson & Johnson said on Wednesday it had found a problem with a batch of drug substance for its COVID-19 vaccine, which did not meet quality standards at Emergent Biosolutions’ production site in Baltimore, Maryland.
The issue was identified and addressed with Emergent and shared with the U.S. Food & Drug Administration, J&J said, adding it was sending more people to supervise manufacturing at the plant.
Workers at the plant manufacturing coronavirus shots for J&J and AstraZeneca accidentally conflated the vaccines’ ingredients several weeks ago, the New York Times earlier reported, adding that Federal officials attributed the mistake to human error.
J&J tapped contract manufacturers Catalent Inc and Emergent to scale up production and meet its global supply targets. Catalent provides the final stage – called fill and finish – while Emergent makes the drug substance.
The company also said it had met its commitment to deliver more than 20 million single-shot vaccines by the end of March in the United States.
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